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FDA 510(k)

Drive Rail System

K-Number: K220809 · 2022-04-08

ApplicantOrthoPediatrics Corp.
Decision Date2022-04-08
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Drive Rail System is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2022-04-08 under approval number K220809. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Drive Rail System?

Drive Rail System is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K220809.

When was Drive Rail System approved by the FDA?

Drive Rail System received FDA 510(k) clearance on 2022-04-08, under approval number K220809.

What company makes Drive Rail System?

Drive Rail System is manufactured by OrthoPediatrics Corp..

What is the FDA product code for Drive Rail System?

The FDA product code for Drive Rail System is KTT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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